Low-Intensity Focused Ultrasound Targeting the Stellate Ganglion for Regulating Autonomic Nerve Function and Sleep Quality in Perioperative Patients With Cardiovascular Diseases (US-REST)
12 maggio 2026 aggiornato da: Songyun Wang, Renmin Hospital of Wuhan University
Low-Intensity Focused Ultrasound Targeting the Stellate Ganglion for Regulating Autonomic Nerve Function and Sleep Quality in Perioperative Patients With Cardiovascular Diseases: A Multicenter, Double-Blind, Randomized Controlled Trial
The goal of this multicenter, double-blind, randomized controlled trial is to evaluate the efficacy and safety of low-intensity focused ultrasound (LIFU) stellate ganglion modulation for improving autonomic function and sleep quality in perioperative cardiovascular disease patients.
The main questions it aims to answer are:
- Does LIFU improve heart rate variability and sleep characteristics from baseline at 3-7 days post-surgery compared to sham ultrasound?
- Does LIFU improve serological markers, vital signs, Pittsburgh Sleep Quality Index (PSQI), and reduce >30-second perioperative arrhythmias?
- What is the safety profile of LIFU in this population? 200 eligible patients will be randomized 1:1 to receive either active LIFU (2.0W, 1MHz, 50% duty cycle, 30min daily for 3-7 days) plus standard care, or identical sham ultrasound plus standard care. A four-party double-blind design (subjects, operators, assessors, analysts) will be implemented. The study will run from May 1, 2026 to April 1, 2027 at 6 centers in China.
Participants will:
- Complete pre-surgery screening and baseline assessments (PSQI, 12h ECG/sleep monitoring, residual blood sample collection)
- Receive daily assigned ultrasound intervention for 3-7 consecutive days post-surgery
- Undergo 72h continuous ECG monitoring post-surgery, and repeat assessments at 3-7 days
- Have all adverse events and arrhythmias recorded throughout the study
- May withdraw voluntarily at any time without affecting routine medical care
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Tipo di studio
Interventistico
Iscrizione (Stimato)
200
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Songyun Wang, MD
- Numero di telefono: +86 13871262107
- Email: wsy7982@126.com
Luoghi di studio
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Hubei
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Huangshi, Hubei, Cina, 430060
- Huangshi Central Hospital
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Contatto:
- Kai Zhang, MD
- Numero di telefono: +86 13907230225
- Email: zk9620@163.com
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Jingzhou, Hubei, Cina, 430060
- Jingzhou Central Hospital
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Contatto:
- Keping Yang, MD
- Numero di telefono: +86 18107168679
- Email: 30461400@qq.com
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Wuhan, Hubei, Cina, 430060
- Renmin Hospital of Wuhan University
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Contatto:
- Songyun Wang, MD
- Numero di telefono: +86 13871262107
- Email: wsy7982@126.com
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Wuhan, Hubei, Cina, 430060
- Wuhan Central Hospital
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Contatto:
- Long Wang, MD
- Numero di telefono: +86 15761600527
- Email: 319921605@qq.com
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Wuhan, Hubei, Cina, 430060
- Wuhan Third Hospital
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Contatto:
- Dongsheng Li, MD
- Numero di telefono: +86 18872288277
- Email: lidongsheng693@sina.com
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Xiangyang, Hubei, Cina, 430060
- Xiangyang Central Hospital
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Contatto:
- Tongjian Zhu, MD
- Numero di telefono: +86 15971160197
- Email: whuzhutongjian@126.com
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Yichang, Hubei, Cina, 430060
- Yichang Central People's Hospital
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Contatto:
- Zhuli Guo, MD
- Numero di telefono: +86 15271455251
- Email: guozhuli@yczxyy.com
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
Inclusion Criteria:
- Diagnosed with cardiovascular disease (CVD) and scheduled to undergo cardiology-related surgical treatment
- Able to receive and tolerate the aforementioned cardiology-related surgical treatment
- Aged between 18 and 79 years (inclusive), with no restriction on gender
- Agree to accept random allocation of the treatment strategies
- With clear consciousness, no severe mental disorders or cognitive impairment; voluntarily sign the written informed consent form (ICF) and are willing to actively cooperate with the study treatment
Exclusion Criteria:
- Have used sedative-hypnotic drugs, antipsychotic drugs, opioid analgesics, antihistamines, non-steroidal anti-inflammatory drugs (NSAIDs), central nervous system (CNS) stimulant drugs, or any other medications that alter sleep architecture within the past 30 days
- Have a history of cervical infection, trauma, severe cervical deformity, or prior cervical surgery
- Unable to complete the daily study intervention as required by the trial protocol
- Are participating in another clinical trial, or have participated in other clinical trials with interventions that may interfere with the results of this study
- Have undergone major surgery or general anesthesia within the past 30 days
- Have a history of alcohol abuse
- Are female subjects who are pregnant or lactating, or plan to become pregnant during the study period
- Have severe cognitive impairment, severe psychiatric disorders, epilepsy, or other related neurological disorders
- Have concomitant malignant tumor or severe dysfunction of vital organs
- Have active systemic infection
- Have significant bleeding tendency, or renal failure undergoing regular hemodialysis
- Are deemed unsuitable for the trial by the investigator for any other reason -
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Low-Intensity Focused Ultrasound (LIFU) Intervention Arm
Subjects in this arm will receive low-intensity focused ultrasound (LIFU) intervention on the left stellate ganglion.
Ultrasound parameters: power 2.0 W, frequency 1 MHz, 50% duty cycle, 30 minutes per session, once daily for 3-7 consecutive days.
All subjects will receive guideline-concordant standard perioperative cardiovascular care, including surgery and indicated medications.
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The experimental group receives active low-intensity focused ultrasound (LIFU) treatment: the ultrasound probe is placed on the skin surface corresponding to the left stellate ganglion and fixed with a mechanical arm, with parameters set as power 2.0W, frequency 1MHz, duty cycle 50%, 30 minutes per session, once daily for 3-7 consecutive days.
All enrolled subjects receive standard perioperative cardiovascular care simultaneously throughout the study period.
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Comparatore placebo: Sham Ultrasound Control Arm (Placebo)
Subjects in this arm will receive sham ultrasound intervention with identical operational procedures, device appearance, and parameter settings (no actual energy output) as the intervention arm.
Sessions are once daily for 3-7 consecutive days.
All subjects will receive the same guideline-concordant standard perioperative cardiovascular care as the intervention arm.
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The control group receives sham low-intensity focused ultrasound intervention: the ultrasound probe is placed on the skin surface corresponding to the left stellate ganglion and fixed with a mechanical arm, with the same instrument appearance, operation process, parameter setting display (power 2.0W, frequency 1MHz, duty cycle 50%), duration (30 minutes per session, once daily for 3-7 consecutive days) and subject experience as the experimental group, but no actual ultrasound energy is output.
All enrolled subjects receive standard perioperative cardiovascular care simultaneously throughout the study period.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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SDNN
Lasso di tempo: Pre-operative 24 hours and Post-operative 72 hours
|
Standard deviation of all normal-to-normal intervals measured by wearable Holter monitor; Unit: ms; Measurement device: wearable Holter monitors.
|
Pre-operative 24 hours and Post-operative 72 hours
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Total sleep duration
Lasso di tempo: Pre-operative 24 hours and Post-operative 72 hours
|
Total sleep time measured by wearable sleep monitor; Unit: hours; Measurement device: Wearable sleep monitor.
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Pre-operative 24 hours and Post-operative 72 hours
|
|
SDANN
Lasso di tempo: Pre-operative 24 hours and Post-operative 72 hours
|
Standard deviation of the averages of NN intervals in all 5-minute segments; Unit: ms; Measurement device: wearable Holter monitors.
|
Pre-operative 24 hours and Post-operative 72 hours
|
|
SDNN Index
Lasso di tempo: Pre-operative 24 hours and Post-operative 72 hours
|
Mean of the standard deviations of all NN intervals for all 5-minute segments; Unit: ms; Measurement device: wearable Holter monitors.
|
Pre-operative 24 hours and Post-operative 72 hours
|
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RMSSD
Lasso di tempo: Pre-operative 24 hours and Post-operative 72 hours
|
Root mean square of successive differences between normal heartbeats; Unit: ms; Measurement device: wearable Holter monitors.
|
Pre-operative 24 hours and Post-operative 72 hours
|
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pNN50
Lasso di tempo: Pre-operative 24 hours and Post-operative 72 hours
|
Percentage of successive NN intervals that differ by more than 50 ms; Unit: %; Measurement device: wearable Holter monitors.
|
Pre-operative 24 hours and Post-operative 72 hours
|
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LF power
Lasso di tempo: Pre-operative 24 hours and Post-operative 72 hours
|
Low frequency power of heart rate variability; Unit: ms²; Measurement device: wearable Holter monitors.
|
Pre-operative 24 hours and Post-operative 72 hours
|
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HF power
Lasso di tempo: Pre-operative 24 hours and Post-operative 72 hours
|
High frequency power of heart rate variability; Unit: ms²; Measurement device: wearable Holter monitors.
|
Pre-operative 24 hours and Post-operative 72 hours
|
|
TP
Lasso di tempo: Pre-operative 24 hours and Post-operative 72 hours
|
Total power of heart rate variability; Unit: ms²; Measurement device: wearable Holter monitors.
|
Pre-operative 24 hours and Post-operative 72 hours
|
|
LF/HF ratio
Lasso di tempo: Pre-operative 24 hours and Post-operative 72 hours
|
Ratio of low frequency to high frequency power; Unit: ratio; Measurement device: wearable Holter monitors.
|
Pre-operative 24 hours and Post-operative 72 hours
|
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Wakefulness percentage
Lasso di tempo: Pre-operative 24 hours and Post-operative 72 hours
|
Percentage of time awake during sleep period; Unit: %; Measurement device: Wearable sleep monitor.
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Pre-operative 24 hours and Post-operative 72 hours
|
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Insomnia percentage
Lasso di tempo: Pre-operative 24 hours and Post-operative 72 hours
|
Percentage of time with insomnia symptoms during sleep period; Unit: %; Measurement device: Wearable sleep monitor.
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Pre-operative 24 hours and Post-operative 72 hours
|
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REM sleep percentage
Lasso di tempo: Pre-operative 24 hours and Post-operative 72 hours
|
Percentage of rapid eye movement sleep during total sleep time; Unit: %; Measurement device: Wearable sleep monitor.
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Pre-operative 24 hours and Post-operative 72 hours
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N1 sleep stage percentage
Lasso di tempo: Pre-operative 24 hours and Post-operative 72 hours
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Percentage of N1 sleep stage during total sleep time; Unit: %; Measurement device: Wearable sleep monitor.
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Pre-operative 24 hours and Post-operative 72 hours
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N2 and N3 sleep stages percentage
Lasso di tempo: Pre-operative 24 hours and Post-operative 72 hours
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Combined percentage of N2 and N3 sleep stages during total sleep time; Unit: %; Measurement device: Wearable sleep monitor.
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Pre-operative 24 hours and Post-operative 72 hours
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Sleep efficiency
Lasso di tempo: Pre-operative 24 hours and Post-operative 72 hours
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Ratio of total sleep time to time in bed; Unit: %; Measurement device: Wearable sleep monitor.
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Pre-operative 24 hours and Post-operative 72 hours
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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IL-1β level
Lasso di tempo: Pre-operative 24 hours and Post-operative 72 hours
|
Serum IL-1β concentration; Unit: pg/mL.
|
Pre-operative 24 hours and Post-operative 72 hours
|
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Norepinephrine (NE) level
Lasso di tempo: Pre-operative 24 hours and Post-operative 72 hours
|
Serum norepinephrine concentration; Unit: pg/mL.
|
Pre-operative 24 hours and Post-operative 72 hours
|
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Brain-derived neurotrophic factor (BDNF) level
Lasso di tempo: Pre-operative 24 hours and Post-operative 72 hours
|
Serum brain-derived neurotrophic factor concentration; Unit: pg/mL.
|
Pre-operative 24 hours and Post-operative 72 hours
|
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Pittsburgh Sleep Quality Index (PSQI) score
Lasso di tempo: Pre-operative 24 hours and Post-operative 72 hours
|
Subjective sleep quality assessed using the Pittsburgh Sleep Quality Index questionnaire; Unit: Score on a 0-21 scale, where higher scores indicate worse sleep quality; Method of Measurement: Self-administered questionnaire.
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Pre-operative 24 hours and Post-operative 72 hours
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Number of atrial arrhythmias
Lasso di tempo: Pre-operative 24 hours and Post-operative 72 hours
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Measurement: count of atrial arrhythmia episodes.
Measurement device: wearable Holter monitors.
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Pre-operative 24 hours and Post-operative 72 hours
|
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Duration of atrial arrhythmias
Lasso di tempo: Pre-operative 24 hours and Post-operative 72 hours
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Measurement: Duration of atrial arrhythmia episodes.
Measurement device: wearable Holter monitors.
|
Pre-operative 24 hours and Post-operative 72 hours
|
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TNF-α level
Lasso di tempo: Pre-operative 24 hours and Post-operative 72 hours
|
Serum TNF-α concentration; Unit: pg/mL.
|
Pre-operative 24 hours and Post-operative 72 hours
|
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Neuropeptide Y (NPY) level
Lasso di tempo: Pre-operative 24 hours and Post-operative 72 hours
|
Serum neuropeptide Y concentration; Unit: pg/mL.
|
Pre-operative 24 hours and Post-operative 72 hours
|
|
Melatonin level
Lasso di tempo: Pre-operative 24 hours and Post-operative 72 hours
|
Serum melatonin concentration; Unit: pg/mL.
|
Pre-operative 24 hours and Post-operative 72 hours
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
5 maggio 2026
Completamento primario (Stimato)
1 aprile 2027
Completamento dello studio (Stimato)
1 aprile 2027
Date di iscrizione allo studio
Primo inviato
28 aprile 2026
Primo inviato che soddisfa i criteri di controllo qualità
12 maggio 2026
Primo Inserito (Effettivo)
19 maggio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
19 maggio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
12 maggio 2026
Ultimo verificato
1 aprile 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- WDRY2026-K085
- 82570593 (Altro numero di sovvenzione/finanziamento: National Natural Science Foundation of China (NSFC))
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
INDECISO
Descrizione del piano IPD
Due to considerations for protecting participant privacy, undetermined data ownership, or the absence of a detailed data-sharing policy.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Low-intensity focused ultrasound (LIFU) targeting the left stellate ganglion
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University of Sao Paulo General HospitalNon ancora reclutamento